the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: hyperbaric oxygen therapy, non Hyperbaric Oxygen Therapy.
- Кому может быть актуально
- Состояния в реестре: Ankle Sprain. Базовые параметры: 18 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multicenter, Prospective Clinical Randomized Controlled Study of the Efficacy of Hyperbaric Oxygen on Acute Ankle Sprain
Обзор
Investigators recruited 208 patients with acute ankle sprain who were from the Rehabilitation Department of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2026 to November 2028. Perform the improvement in AOFAS scores and Baird-Jackson ankle scores study and Rehabilitation assessments followed up after 3 years.
Подробное описание
In baseline, 208 patients with i acute ankle sprain were recruited from the Rehabilitation Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from January 2026 to December 2028, and were followed up after 3 years.
Perform the improvement in AOFAS scores and Baird-Jackson ankle scores study and Rehabilitation assessments followed up after 3 years. The Hyperbaric oxygen group treatment was administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Oxygen was inhaled for 40 minutes (20 minutes of oxygen inhalation, 5-minute rest, 20 minutes of oxygen inhalation, decompression), once daily for 14 consecutive days. The control group treatment at an atmospheric pressure of 1.4 ATA, inhaling 21% oxygen by volume. Oxygen inhalation schedule: 40 minutes (inhale oxygen for 20 minutes, rest for 5 minutes, inhale oxygen for 20 minutes, decompression), once a day for 14 consecutive days.
Two person analyzed the above data, and record abnormal results.
Вмешательства
- Другое hyperbaric oxygen therapy
The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Oxygen inhalation time: 40 minutes (inhaling oxygen for 20 minutes, resting for 5 minutes, inhaling oxygen for 20 minutes, decompression), once daily, for 14 consecutive days. (Commenced immediately after randomisation) - Другое non Hyperbaric Oxygen Therapy
The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%, oxygen inhalation time: 40 minutes (20 minutes of oxygen inhalation, 5 minutes rest, 20 minutes of oxygen inhalation, decompression), once daily, for 14 consecutive days. (Commences immediately after randomisation)
Первичные конечные точки
- AOFAS score [Срок оценки: 3 years]
- Baird-Jackson ankle score [Срок оценки: 3 years]
Вторичные конечные точки (6)
- pain scores [Срок оценки: 3 years]
- ankle swelling [Срок оценки: 3 years]
- high-frequency ultrasound findings [Срок оценки: 3 years]
- Ankle MRI [Срок оценки: 3 years]
- patient's overall evaluation of treatment (PGIC) [Срок оценки: 3 years]
- HAMA scale score [Срок оценки: 3 years]
Критерии участия
Критерии включения
- Unilateral ankle sprain;
- Swelling, bruising, and pain at the site of the sprain;
- Injury occurring within 72 hours;
- MRI examination clearly shows ligament damage.
Критерии исключения
- X-ray shows ankle fracture;
- Ankle has skin lesions or skin diseases;
- History of lower limb and pelvic surgery;
- Obvious neurological or psychiatric disorders that may interfere with assessment;
- Severe ligament injuries or joint instability requiring surgical treatment;
- Previous ankle injuries, persistent pain or functional limitations;
- Pneumothorax, severe emphysema, active bleeding, or other diseases with contraindications for hyperbaric oxygen therapy.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07405281 · 2025-1461